340B Program: BIO Comments on Health Resources and Services Administration (HRSA) Notice on the Enrollment and Recertification of Entities in the 340B Pricing Program

Re:      Proposed Project: Enrollment and Recertification of Entities in the 340B Drug Pricing Program (OMB No. 0915–0327)—Revision

Dear Commander Pedley:

            The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments on the Health Resources and Services Administration (“HRSA”) notice on the enrollment and recertification of entities in the 340B pricing program.

            BIO is the largest trade organization to serve and represent the biotechnology industry in the United States and around the globe.  BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States.  BIO members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products.

            As the representative of an industry that is devoted to improving health care through the discovery of new therapies, BIO understands the significance of the 340B drug pricing program, which requires manufacturers of covered outpatient drugs to charge no more than a defined ceiling price to certain specified safety net providers, as defined by statute.[1]  The 340B drug pricing program significantly lowers prices for drugs to entities that often serve low-income or disadvantaged individuals.

            As set forth in Section 7102 of the Patient Protection and Affordable Care Act (PPACA), HRSA is now statutorily required to annually recertify all 340B covered entities.  Prior to PPACA, HRSA recertified only certain entities annually (e.g., STD, TB, HIV/AIDS grantees), as expressly required under Section 340B (a)(7) of the Public Health Service Act.[2]   As there are currently 20 entity types eligible for the 340B program, each has a unique set of criteria that HRSA uses to determine eligibility.  The recertification process, in general, includes verification of grant status, updating contact information, verification of all eligibility requirements as defined by statute, updating of the entity's intention to bill Medicaid, and when applicable, GPO exclusion attestation.[3]    

            HRSA began a phased approach to recertification in August 2011, which included a comprehensive communication strategy notifying covered entities' of their recertification requirements.  In April 2012, all hospitals entering the program prior to June 1, 2011were required to recertify entity information with HRSA, marking the first time hospitals were required to recertify eligibility in the 340B program.  HRSA has indicated that recertification covers the parent site as well as all registered outpatient child sites in the program database.[4]

            To ensure the process is as smooth as possible for hospitals and to answer their outstanding questions, HRSA has hosted a series of webinars and also has posted new FAQs on its website explaining the recertification process.  On April 26, HRSA hosted a webinar for manufacturers and wholesalers to update them on the status of hospital recertification.  BIO appreciates HRSA's outreach and communication to all stakeholders regarding this very important process, and believes it is reflective of the Agency's commitment to program integrity and compliance. 

            BIO supports HRSA in its efforts as it administers and oversees the recertification process, and believes that this process will enable the Agency to verify that all covered entities continue to meet the statutory requirements for program participation.  We offer the following comments to ensure that the goals of the enrollment and recertification process are met.

[1]See 42 U.S.C. § 256b (describing the Public Health Service (“PHS”) Drug Pricing Program).


[3]See Letter from Administrator Mary Wakefield to Senator Charles Grassley dated October 21, 2011. 

[4]See, e.g., HRSA FAQ "My Hospital Covered entity submitted a change request form, does this mean we are recertified?"

Read the full comment letter (PDF)